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OpenTrials
Completed

NCT Number: NCT03273842

A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers

This study compares the immune response to the proposed biosimilar PF-06881894 and the US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6 milligrams [mg]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1 of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two treatment periods. In addition, safety assessments will be conducted throughout the study.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seaview A Quotient Clinical Business, Coral Gables, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males or females between 18 and 65 years of age (both inclusive) with body mass index between 19 and 30 kg/m2, inclusive, and body weight of not <50 kg or >95 kg, will be enrolled in this study.

Exclusion criteria

  • Hematologic laboratory abnormalities (including leukocytosis [defined as total leukocytes >11,000/mcL], leukopenia [defined as total leukocytes <4000/mcL], or neutropenia [defined as absolute neutrophil count <1500/mcL] or thrombocytopenia [defined as platelet count of <150,000/mcL]) or other clinically significant abnormal laboratory evaluations.
  • Lack of adequate hepatic or renal reserve.
  • Any active systemic or immunologic disease or condition.
  • History of biological growth factor exposure.
  • Received live vaccination or exposure to communicable viral diseases within 4 weeks prior to Screening.

Treatment and study plan

PF-06881894

Biological

pre-filled syringe 6 mg

US-approved Neulasta

Biological

pre-filled syringe 6 mg

Primary outcomes

  1. The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and confirmed postdose positive anti-pegfilgrastim antibody test result at any time during the study.

    Time frame: 90 days (through Period 1 Day1 to Period 2 Day 60 or final visit)

Secondary outcomes

  1. The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and postdose positive neutralizing antibody result at any time during the study.

    Time frame: 90 Days (through Period 1 Day 1 to Period 2 Day 60 or final study visit)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase 1, Randomized Open Label, Multiple Dose, Parallel Study To Assess The Immunogenicity Of Multiple Subcutaneous (SC) Doses Of The Proposed Pegfilgrastim Biosimilar (PF-06881894) And Us-approved Neulasta (Registered) In Healthy Volunteers

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2017
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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